Kornimate/medical-research-clean huggingface dataset:
fasting mimicking diet in prostate cancer and metabolic syndrome

Conditions: Prostate Cancer; Metabolic Syndrome; Intermittent Fasting

Summary: this is a prospective observational cohort study of patients with prostate cancer who have a metabolic syndrome. the study aims to evaluate the role of intermittent fasting (fasting mimicking diet) in these patients. the primary end point is metabolic health and the secondary endpoint is quality of life.

cancer is a complex set of conditions which collectively comprise the second biggest cause of death in the western world. in addition, these diseases, along with their various treatments, are associated with significant illness, as well as a host of debilitating symptoms. two very common problems are cancer fatigue, as well as metabolic changes which can cause much suffering in and of themselves. patients with advanced cancers, as well as many patients undergoing surgery, radiation therapy as well as chemotherapy all complain of fatigue, to a greater or lesser extent. many gain or lose weight, and develop associated metabolic changes in uninvolved body systems, which can cause a significant health burden on the patients, as well as the healthcare system as a whole. little is known about the mechanisms which underlie these symptoms. various biologic processes have been implicated including inflammation and other changes in body metabolism. there is urgent need to better understand these processes, which cause so much suffering in cancer patients, so as to potentially develop more effective solutions.

Eligibility criteria:
inclusion criteria: * patients with biopsy-proven prostate cancer having features of a metabolic syndrome, receiving standard treatment options for their disease. exclusion criteria: * patients without a diagnosis of prostate cancer * life expectancy less than 1 year * children under the age of 18 * individuals who are allergic to nuts or soy * individuals with a body mass index (bmi) \<18.5 * individuals who have been severely weakened by a disease or medical procedure * individuals who are taking medications which may not be safely consumed with a calorie restricted diet unless authorised in writing by a licensed physician * individuals with a history of significant cardiac disease, particularly uncompensated congestive heart failure nyha grade 2 or more or lvef \<40% on any prior assessment * individuals with a history of syncope (fainting) with calorie restriction or other medical co-morbidities * individuals who have special dietary needs that are incompatible with the prolon® meal plan * individuals with liver or kidney disorders that may be affected by the very low glucose and protein content of the diet

Keywords: fasting mimicking diet
efficacy of an oral hygiene implant protocol

Conditions: Peri-implant Mucositis

Summary: this study is designed to evaluate the effectiveness of cleaning around implants that hold a full denture in the mouth. different oral hygiene protocols will be compared. areas to measure are gum tissue color and consistency, bleeding and cleanliness. a questionnaire will be provided at the end of the study. this is a proof of concept study.

the aim of this proof of concept study is to evaluate the effect of an oral hygiene regimen of manual brushing and water flossing on implant retained removable complete dentures. this is a randomized, two arm clinical trial that will compare the traditional oral hygiene regimen to the experimental regimen. data will be evaluated at baseline, 3 weeks and 6 weeks. photographs of the tissue and denture will be taken.

Eligibility criteria:
inclusion criteria: * have a maxillary and/or mandibular implant supported, removable complete denture that is supported by at least 2 implants in good, serviceable condition * good general health, with no diseases which could impact periodontal health * able to read and understand english * willing to return for all appointments * at least 30% bop * probing depths less or equal to 5mm exclusion criteria: * subjects who are currently pregnant * mobility of implant * subjects who have diabetes * subjects who smoke * subjects with any serious medical condition which the investigator feels may impact participation in the study
dna analysis of discarded media drops from the clinical ivf cycles

Conditions: Infertility

Summary: performing dna analysis of discarded media drops from the clinical ivf cycles completed in our center

the purpose of this research study is to investigate for the presence of dna in the surrounding media that is remaining after human clinical ivf cycles, to have a non-invasive way of obtaining markers of embryo chromosome numeration. media recovered from the clinical ivf laboratory is typically discarded during an ivf cycle. genomic technologies will be used to analyze the otherwise discarded media drop for chromosome counting.

Eligibility criteria:
inclusion criteria: * any women undergoing an in vitro fertilization cycle (ivf) at the colorado center for reproductive medicine that is also having comprehensive chromosomal screening (ccs) of embryos exclusion criteria: -
laparoscopic sleeve gasterectomy with or without pyloric botulinum neurotoxin injection

Conditions: Morbid Obesity

Summary: leakage is the most common complication after laparoscopic sleeve gastrectomy which may amount to 20% in some studies. we hypothesize that clostridium botulinum neurotoxin a (btx-a) injection into the pyloric sphincter during the operation may decrease the risk of postoperative gastric leakage.

laparoscopic sleeve gastrectomy (lsg) provides similar weight loss and resolution of obesity comorbidities to that of duodenal switch and roux-en-y gastric bypass. inspite of its encouraging results, the pretended feasibility of the operative procedure can be associated with a remarkable operative morbidity. the main reason is gastric leakage from stable line which occurs in about 0-20% of the cases. the main accepted cause of leakage is formation of a high gastric tube pressure. injection of btx-a into the pyloric sphincter intraoperative will cause temporal paralysis of pyloric sphincter muscles postoperatively; so the pressure inside the gastric pouch will be decreased abolishing the formation of high pressure tube with subsequent leakage.

Eligibility criteria:
inclusion criteria: body mass index \>40 or \>35 with hypertension or dm exclusion criteria: previous bariatric surgery
phase i double-blind, placebo-controlled study of azd7442

Conditions: COVID-19

Summary: azd7442 mabs are being evaluated for administration to prevent or treat covid-19. this phase i study will gather important information on the safety and tolerability of azd7442.

severe acute respiratory coronavirus 2 is a novel coronavirus that appears to have first emerged in china in november 2019 causing cases of atypical pneumonia. since then, the covid-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. as of 22 december 2020, the virus had spread to all corners of the globe, involving 218 countries/regions with over 78.00 million confirmed cases reported and more than 1.71 million associated deaths. as a response to the ongoing pandemic, astrazeneca is developing mabs to the sars-cov-2 spike protein. the sars-cov-2 spike protein contains the virus's receptor binding domain, which enables the virus to bind to receptors on human cells. by targeting this region of the virus's spike protein, antibodies can block the virus's attachment to human cells, and, therefore, are expected to block infection. azd7442, a combination of 2 of these mabs (azd8895 and azd1061), is being evaluated for administration to treat or prevent covid-19. there are currently one ongoing phase i study and two ongoing phase iii studies with azd7442, in addition to this treatment study. randomization of approximately 40 japanese participants is planned.

Eligibility criteria:
inclusion criteria: * participants must be japanese men and women and 18 to 55 years of age inclusive, at the time of signing the informed consent. * negative results from both sars-cov-2 qrt-pcr and serology tests * healthy by medical history, physical examination, and safety laboratory tests, according to the judgement of the investigators exclusion criteria: * fever above 37.5°c by the time when the participant is randomised; a participant excluded for transient acute illness may be dosed if the illness resolves by the time of randomisation. * history of infection with sars or mers * any drug therapy within 7 days prior to day 1
a study in head and neck cancer

Conditions: Head and Neck Cancer

Summary: this study will begin with a 30 participant lead-in part: these 30 participants will receive cetuximab manufactured by imclone on a weekly basis in combination with other chemotherapy drugs \[cisplatin or carboplatin plus 5-fluorouracil (5-fu)\] administered every 3 weeks. after 18 weeks, participants who benefit from this treatment may continue to receive cetuximab once-weekly until progression of the disease, an unacceptable side effect occurs, participants withdraw consent, or the study is closed. in the second part of this study, 200 participants will be randomized in 2 arms: * 100 participants will receive commercial cetuximab manufactured by imclone (group a) * 100 participants will receive cetuximab manufactured by boehringer ingelheim (group b). all these 200 participants will receive other chemotherapy drugs (cisplatin or carboplatin plus 5-fu) administered every 3 weeks. after 18 weeks, participants who benefit from this treatment may continue to receive cetuximab once-weekly until progression of the disease, an unacceptable side effect occurs, participants withdraw consent, or the study is closed.


Eligibility criteria:
inclusion criteria: * head and neck cancer that was confirmed by tissue biopsy or cytology * disease not suitable for local therapy * measurable or evaluable disease * karnofsky performance status (kps) score of at least 70 * organs are functioning well (bone marrow reserve, liver and kidney) * life expectancy of at least 12 weeks * signed informed consent document exclusion criteria: * receiving another investigational medication within the last 30 days * prior chemotherapy, except if given as part of a multimodal treatment for locally advanced head and neck cancer that was completed more than 4 months prior to study entry. * nasopharyngeal carcinoma * previous treatment with monoclonal antibody therapy or other signal transduction inhibitors or epidermal growth factor receptor (egfr) targeting therapy except for prior cetuximab treatment given as part of a multimodal treatment for locally advanced head and neck cancer that was completed more than 4 months prior to study entry. * uncontrolled high blood pressure * heart disease or had a heart attack within the last year * currently have an infection that requires for you to take an iv antibiotic * currently receiving other therapies for your cancer, such as chemotherapy, radiation therapy, immunotherapy, and hormonal therapy * medical or psychological condition that would not permit the participant to complete the study or sign informed consent * known drug abuse (with the exception of alcohol abuse) * known allergic reaction against any of the components of the study treatment * second primary malignancy that is clinically detectable at the time of consideration for study enrollment * have had another type of cancer within the last 2 years * you are currently pregnant or breastfeeding * you are considering becoming pregnant or fathering a child
safety and efficacy of levamisole combined with cyclosporine a in patients with subclinical paroxysmal nocturnal hemoglobinuria and pnh in the setting of another bone marrow failure syndromes(pnh-2013)

Conditions: Paroxysmal Nocturnal Hemoglobinuria; Hemoglobinuria; Hemoglobinuria, Paroxysmal; Proteinuria; Urination Disorders; Thrombosis; Bone Marrow Failure; Aplastic Anemia,; Anemia, Hemolytic

Summary: paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is designed to evaluate the safety and efficacy of levamisole combined with cyclosporine a in patients with subclinical paroxysmal nocturnal hemoglobinuria and pnh in the setting of another bone marrow failure syndromes

paroxysmal nocturnal hemoglobinuria (pnh) is an acquired clonal disorder of the hematopoietic stem cell characterized by intravascular hemolysis, hemoglobinuria, anemia, and thrombosis, patients may be at high risk of thrombosis and may develop bone marrow failure or aplastic anemia, with low white blood cell and platelet counts,because the manifestation and pathologic processes are complicate,the treatment is very difficult,this study is designed to evaluate the safety and efficacy of levamisole combined with cyclosporine a in patients with subclinical paroxysmal nocturnal hemoglobinuria and pnh in the setting of another bone marrow failure syndromes

Eligibility criteria:
inclusion criteria: 1. clinical and biochemical signs of subclinical paroxysmal nocturnal hemoglobinuria and pnh in the setting of another bone marrow failure syndromes 2. diagnosis confirmed by ham's test or flow cytometry patients have any flow cytometry data 3. patient should complete levamisole study for at least half a year exclusion criteria: 1. active infection which requires antibiotic treatment 2. pregnant or lactating women 3. epilepsy and mental illness 4. kidney and liver function abnormal

Keywords: paroxysmal nocturnal hemoglobinuria anemia hematologic diseases bone marrow failure immunologic factors physiological effects of drugs levamisole cyclosporine a
positron emission tomography in extrapulmonary tuberculosis

Conditions: Extrapulmonary Tuberculosis; Lymph Node Tuberculosis; Bone Tuberculosis

Summary: tuberculosis (tb) remains a major public health problem. in extra-pulmonary forms, evidence of bacteriological cure is difficult to be obtained raising the need for other therapeutic assessment tools. 18f-fluoro-deoxy-glucose (fdg) is a glucose analogue widely used in positron emission tomography (pet). its uptake is high in cancer cells and in inflammatory cells, especially in active tb foci. the hypothesis is a decrease in the uptake of fdg in the foci of tb during treatment permitting a non-invasive monitoring of therapeutic response. the main objective is to describe the evolution under treatment of the fdg uptake in pet imaging in tb foci in patients cured from lymph node and bone tb. secondary objectives are to compare the decrease of fdg uptake according to type of location, to define the frequency of localizations revealed by fdg-pet and their impact on therapeutic management at the beginning and the end of treatment, and to describe the evolution of pet in patients not cured.

longitudinal observational multicenter pilot study. 55 patients to be included total duration of the study: 51 months. inclusion period: 27 months follow up period: 18 to 24 months number of participating centers: 11 average number of inclusion per month per center: 1-2

Eligibility criteria:
inclusion criteria: * adults * affiliated to a social security system or "ame" * patient informed of the objectives and constraints of the study and giving informed consent * patient can keep lying valid at least 30 minutes * patient not hiv infected or, if infected, with cd4 counts\> 200/mm3 for at least 3 months exclusion criteria: * suspicion of other concurrent infection * severe immunosuppression in case of hiv infection * inflammatory disease * pregnant or nursing women * radiation therapy * uncontrolled diabetes * prolonged corticosteroid therapy (\> 20mg/day) * patient unable to sustain injected ct scan and mri

Keywords: extrapulmonary tuberculosis fdg-tep cohorts
the pancreas interception center (pic) for early detection, prevention, and novel therapeutics

Conditions: Pancreatic Ductal Adenocarcinoma; Pancreatic Cyst; Chronic Pancreatitis; Fatty Pancreas; Genetic Pancreatic Cancer; Genetic Pancreatitis; BRCA Mutation; Lynch Syndrome; FAP; Familial Atypical Multiple Mole-Melanoma; PALB2 Gene Mutation; Peutz-Jeghers Syndrome; Ataxia Telangiectasia

Summary: the long-term goal of our pic is to develop effective strategies that can be applied clinically at the point-of-care to prevent, intercept, or detect pdac at an early stage, thereby reducing pdac burden and saving lives.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * moffitt cancer center patients presenting with a pancreatic cyst, and/or inherited syndrome that predisposes them to pancreatic ductal adenocarcinoma (pdac) * moffitt cancer center patients undergoing evaluation for localized/early stage pdac. * moffitt cancer center patients with a combination of pdac risk factors such as a history of chronic or new-onset diabetes, pancreatitis, obesity, tobacco exposure, toxin exposure and/or heavy alcohol consumption.

Keywords: pancreas database
implantable systems performance registry

Conditions: Spinal Cord Stimulation; Deep Brain Stimulation; Drug Infusion (Implantable Pumps); Sacral Neuromodulation

Summary: the implantable systems performance registry (ispr) was developed to evaluate the long-term reliability and performance of market-released medtronic neuromodulation infusion and stimulation products. completion notice: the ispr was created by medtronic to monitor the performance of commercially available products. this registry was initially designed to track performance of medtronic's implantable infusion and spinal cord stimulation systems beginning in august 2003 and june 2004, respectively. medtronic dbs systems were added to the ispr in june 2009, and sacral neuromodulation systems in april 2010. medtronic retired the ispr in april 2016 and merged the data collected from this registry into the product surveillance registry (psr). please refer to that record, clinical trials identifier: nct01524276, for further information.


Eligibility criteria:
inclusion criteria: * scheduled for an implant or replacement with a market-released medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator exclusion criteria: * patient who is or will be inaccessible for follow-up at an ispr study site * patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study

Keywords: registry pain chronic pain back pain intractable spasticity parkinson's disease essential tremor dystonia implantable pumps incontinence
a randomized trial of exparel vs saline in opioid reduction of pain management following lumbar spine surgeries.

Conditions: Lumbar Spine Degeneration

Summary: the purpose of this study is to establish a relationship between liposomal bupivacaine surgical site injection and postop opioid utilization.

multiple studies have shown that people who are taking opioids for acute pain have a greater likelihood of long-term opioid use. many efforts have been made to reduce postop pain and opioid use, including developments in incisional site injections of local anesthetics, continuous incisional site anesthetic pain pumps, as well as multimodal comprehensive pain management, yet patients undergoing lumbar spine surgeries continue to depend on opioids for relief. liposomal bupivacaine (lb) (exparel) is a novel formulation of long-acting bupivacaine, lasting for up to 72 hours following injection. lb has been shown to be efficacious in reducing postop pain and opioid utilization in several different surgical settings, however its utility in spine surgeries has still yet to be established. the goal of this study is to determine the efficacy of liposomal bupivacaine vs saline in lumbar spine surgeries in reducing opioid utilization as well as determine if there difference patient reported outcomes and length of hospital stay.

Eligibility criteria:
inclusion criteria: * patients undergoing isolated lumbar spine procedures using a posterior approach. * surgical spine procedures include: * single-level lumbar spine surgeries with or without fusion * multi-level lumbar spine surgeries with or without fusion exclusion criteria: * procedures involving intrathecal space * patients with documented allergy to local anesthetics (bupivacaine, lidocaine, procaine, benzocaine). * acute lumbar trauma that requires immediate spine stabilization * revision of failed back surgeries (including nonunion and malunion) * revision of wound or hardware * contraindication to regional anesthesia * patients with chronic use of opioid medications * liver dysfunction (inr \> 1.5, albumin \ 2mg/dl) * renal dysfunction (egfr \< 60ml/min/1.73m2) * severe chronic obstructive pulmonary disease requiring continuous oxygen supplementation * unable to give informed consent * pregnancy
cbt insomnia teens: augmenting ssris to improve youth depression

Conditions: Insomnia; Depression

Summary: this study is a randomized controlled trial that tests the effectiveness of cognitive behavior therapy (cbt) for insomnia with comorbid depression in youth aged 12 through 19 who have recently begun selective serotonin re-uptake inhibitor (ssri) antidepressants. cbt is compared with a control condition of sleep hygiene education.

160 youth with depression and comorbid insomnia who have just initiated a course of ssri antidepressants will be randomized to insomnia-focused cognitive behavior therapy (cbt-i) or an attention control condition of sleep hygiene (sh) education. all participants will have in-person treatment sessions and will complete sleep diaries and wear an actigraph to record activity levels. participants will be followed for 12 months. primary depression outcomes are score on the clinical global impressions improvement (cgi-i) and major depressive disorder diagnostic remission; primary sleep outcomes are actigraphy total sleep time and score on the insomnia severity index (isi). secondary outcomes include additional sleep and depression outcomes. the study will also include economic analyses.

Eligibility criteria:
inclusion criteria: * age 12 to 19 * major depression based on diagnostic and statistical manual of mental disorders (dsm-5) criteria * recent dispense of ssri antidepressant * subjective complaint of insomnia ≥ one month * score of ≥ 9 on insomnia severity index exclusion criteria: * active, progressive physical illness or neurological degenerative disease * sleep apnea, restless legs, or limb movements during sleep * diagnosis of delayed sleep phase syndrome (dsps) * mental retardation, autism spectrum disorder (asd), or other significant pervasive developmental disability (pdd) * sleep treatments including over-the-counter (otc) sleep medication or cbt for insomnia * medications known to alter sleep * diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder

Keywords: insomnia depression teen ssri cbt youth